Rheumatoid Arthritis

Remicade, Inflectra, Renflexis, Ixifi

Indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately-to-severely active rheumatoid arthritis in combination with methotrexate

3 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter

If incomplete response is noted, dose may be increased to 10 mg/kg OR increasing the dosing frequency to q4Weeks

Psoriatic Arthritis

Remicade, Inflectra, Renflexis, Ixifi

Indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis

5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter

May be used with methotrexate

Plaque Psoriasis

Remicade, Inflectra, Renflexis, Ixifi

Indicated for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate

Should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician

5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter

Can be used with or without methotrexate

Crohn Disease

Remicade, Inflectra, Renflexis, Ixifi

Indicated for moderately-to-severely active Crohn disease in patients who have had inadequate response to conventional therapy

Also, indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn disease

5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter

For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg

Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue

Ulcerative Colitis

Remicade, Inflectra, Renflexis, Ixifi

Indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adults with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

5 mg/kg IV at 0, 2, and 6 weeks, then every 8 weeks

Ankylosing Spondylitis

Remicade, Inflectra, Renflexis, Ixifi

Indicated for reducing signs and symptoms in patients with active ankylosing spondylitis

Crohn Disease

Remicade, Inflectra, Renflexis, Ixifi

Reduction of signs and symptoms and induction and maintenance of clinical remission in pediatric patients aged ≥6 year with moderately to severely active Crohn disease who have had inadequate response to conventional therapy

Discontinue if patient develops serious infection or sepsis; reported infections include the following:

(1) Active tuberculosis, including reactivation of latent disease (frequently present with disseminated or extrapulmonary disease); test for latent tuberculosis before use and during therapy; treat latent infection before use

Rare postmarketing cases of HSTCL are reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with infliximab

Reports have also included 1 patient being treated for psoriasis and 2 patients being treated for rheumatoid arthritis

Most reported cases with infliximab have occurred with concomitant treatment with azathioprine or 6-mercaptopurine (6-MP), though cases have been reported in patients receiving azathioprine or 6-MP alone

Contraindications

Active serious infections

Documented hypersensitivity

Doses exceeding 5 mg/kg should not be administered to patients with moderate-to-severe heart failure (NYHA Class III/IV); treatment with 10 mg/kg was associated with an increased incidence of death and hospitalization due to worsening heart failure

Cautions

Worsening or new onset
congestive heart failure
reported with TNF
blockers; Exercise
caution when using in
patients who have heart
failure; TNFalpha
inhibitors should only be
considered in patients
with HF if there are no
other reasonable treatment options, and then consider only in patients with compensated HF

Hypersensitivity reactions reported; most hypersensitivity reactions, which include anaphylaxis, urticaria, dyspnea, and/or hypotension, have occurred during or within 2 hr of infusion

Risk of tuberculosis, histoplasmosis, and other opportunistic infections, as well as hepatitis B reactivation; test for HBV infection before starting infliximab; monitor HBV carriers during and several months after therapy

Readministration after period of no treatment resulted in higher incidence of infusion reactions than was seen with regular maintenance treatment (4% vs <1%)

Consider empiric antifungal therapy for patients who develop a systemic illness on infliximab and reside or travel to regions where mycoses are endemic

Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hr of initiation of infliximab infusion; cases of transient visual loss have been reported during or within 2 hr of infliximab infusion; monitor patients during infusion and if serious reaction occurs, discontinue infusion

Use caution in patients with history of seizures; discontinue therapy if significant adverse reactions develop

Severe hepatic reactions occurred between 2 weeks to more than 1 year after initiation of infliximab; elevations in hepatic aminotransferase levels were not noted prior to discovery of the liver injury in many of these cases

Occurrence of leukemia and new-onset psoriasis is reported in patients treated with TNF blockers

Drug interactions overview

Information on concomitant use of infliximab products with other biological therapeutics used to treat the same conditions is insufficient; concomitant use of infliximab with these biologics is not recommended due to the possibility of an increased risk of infection

Coadministration of TNF blockers with abatacept is associated with greater risk of serious infection than use of TNF blockers alone; concurrent use is not recommended

Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection

Live vaccines or therapeutic infectious agents should not be given with infliximab; bring pediatric patients up to date with all vaccinations prior to initiating therapy; at least a six month waiting period following birth is recommended before administration of live vaccines to infants exposed in utero to infliximab

Administration of live virus vaccines should be delayed or avoided while patient is taking infliximab

Due to the risk of HSTCL, carefully assess the risk/benefit especially if the patient has Crohn disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment

Formation of CYP450 enzymes may be suppressed by increased levels of cytokines (eg, TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation; infliximab products may antagonize cytokine activity and normalize the formation of CYP450; upon initiation or discontinuation of treatment in patients being treated with CYP450 substrates with a narrow therapeutic index (eg, warfarin, cyclosporine, or theophylline), monitor and adjust doses as needed

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Pregnancy & Lactation

Pregnancy

It is not known whether therapy can cause fetal harm when administered to pregnant woman or can affect reproduction capacity; administer therapy to a pregnant woman only if clearly needed

As with other IgG antibodies, drug crosses placenta; drug has been detected in serum of infants up to 6 months following birth; consequently, these infants may be at increased risk of infection, including disseminated infection which can become fatal; >6 month waiting period following birth recommended before administration of live vaccines (eg, BCG vaccine or other live vaccines, such as the rotavirus vaccine) to these infants; cases of agranulocytosis in infants exposed in utero also reported

Lactation

Not known whether drug excreted in human milk or absorbed systemically after ingestion; because many drugs and immunoglobulins are excreted in human milk, and potential for adverse reactions in nursing infants, women should not breastfeed their infants while on therapy; a decision should be made whether to discontinue nursing or discontinue drug, taking into account importance of drug to mother

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

IV Incompatibilities

IV Preparation

Dilute total volume of reconstituted infliximab solution dose to 250 mL with sterile 0.9% NaCl, by withdrawing a volume equal to volume of reconstituted infliximab from 0.9% NaCl 250 mL bottle or bag

Do not dilute reconstituted infliximab solution with any other diluent; slowly add the total volume of reconstituted infliximab solution to 250 mL infusion bottle or bag; gently mix; final diluted concentration should range between 0.4 - 4 mg/ml

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The above information is provided for general
informational and educational purposes only. Individual plans may vary
and formulary information changes. Contact the applicable plan
provider for the most current information.

View explanations for tiers and
restrictions

Tier

Description

1

This drug is available at the lowest co-pay. Most
commonly, these are generic drugs.

2

This drug is available at a middle level co-pay. Most
commonly, these are "preferred" (on formulary) brand drugs.

3

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs.

4

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

5

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

6

This drug is available at a higher level co-pay. Most
commonly, these are "non-preferred" brand drugs or specialty
prescription products.

NC

NOT COVERED – Drugs that are not
covered by the plan.

Code

Definition

PA

Prior Authorization Drugs that
require prior authorization. This restriction requires that
specific clinical criteria be met prior to the approval of the
prescription.

QL

Quantity Limits Drugs that
have quantity limits associated with each prescription. This
restriction typically limits the quantity of the drug that will
be covered.

ST

Step Therapy Drugs that have
step therapy associated with each prescription. This restriction
typically requires that certain criteria be met prior to
approval for the prescription.

OR

Other Restrictions Drugs that
have restrictions other than prior authorization, quantity
limits, and step therapy associated with each prescription.